Addiction, Abuse and Misuse
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Prior to initiation, assess the risks for opioid addiction, abuse, and misuse. Monitor regularly for development of these behaviors and conditions during treatment.
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Increased risk in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (eg, major depression).
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To reduce these risks, prescribe the smallest appropriate quantity and advise the patient on the proper disposal of unused drug.
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
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REMS is required for these products to ensure that the benefits outweigh the risks of addiction, abuse, and misuse.
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Health care providers are strongly encouraged to:
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Complete a REMS-compliant education program,
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Counsel patients and/or their caregivers with every prescription, on safe use, serious risks, storage, and disposal,
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Emphasize the importance of reading the Medication Guide every time it is provided by their pharmacist, and
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Consider other tools to improve patient, household, and community safety.
Opioid-Induced Hyperalgesia and Allodynia
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Opioid-induced hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain.
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Cases of OIH have been reported, both with short-term and longer-term use of opioid analgesics.
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If a patient is suspected to be experiencing OIH, consider decreasing the dose of the current opioid analgesic, or opioid rotation (safely switching the patient to a different opioid moiety).
Life-Threatening Respiratory Depression
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Accidental ingestion of one dose of Nucynta, especially by children, can result in fatal overdose of tapentadol.
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Educate patients and caregivers on how to recognize respiratory depression.
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Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Consider dose reduction if CSA develops.
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Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose
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Assess the potential need for access to naloxone when initiating and renewing therapy.
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Consider prescribing naloxone based on risk factors for overdose (eg, history of opioid use disorder, prior opioid overdose, household members or other close contacts at risk for accidental ingestion or overdose).
Neonatal Opioid Withdrawal Syndrome
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Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening.
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Advise the patient of the risk of neonatal opioid withdrawal syndrome and treat appropriately if opioid use is required for a prolonged period during pregnancy.
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Monitor newborns for signs of neonatal opioid withdrawal syndrome.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
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Risk of profound sedation, respiratory depression, coma and death with benzodiazepines or other CNS depressants including alcohol.
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Reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required. Monitor for signs and symptoms of respiratory depression and sedation.
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If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose.
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Advise patients and caregivers about the risks of respiratory depression and sedation when used with benzodiazepines or other CNS depressants. Do not operate heavy machinery until the effects of concomitant use have been determined.
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Screen for the risk of substance use disorders.
Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients
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Contraindicated to use Nucynta in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.
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Patients with Chronic Pulmonary Disease:
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Increased risk for decreased respiratory drive including apnea in patients with significant COPD or cor pulmonale, and those with substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression.
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Elderly, Cachectic, or Debilitated Patients:
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Monitor these patients closely especially during initiation and titration of Nucynta, and when given concomitantly with other drugs that depress respiration. Consider using non-opioid analgesics in these patients.
Serotonin Syndrome with Concomitant Use of Serotonergic Drugs
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Discontinue Nucynta if serotonin syndrome is suspected.
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Risk for serotonin syndrome during concomitant use with serotonergic drugs including SSRIs, SNRIs, TCAs, triptans, 5-HT3 receptor antagonists, drugs that affect the serotonergic neurotransmitter system (eg, mirtazapine, trazodone, tramadol), certain muscle relaxants (eg, cyclobenzaprine, metaxalone), and drugs that impair metabolism of serotonin (including MAO inhibitors).
Adrenal Insufficiency
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Cases of adrenal insufficiency have been reported with opioid use, more often following greater than 1 month of use.
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If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible.
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If confirmed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers.
Severe Hypotension
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Nucynta may cause severe hypotension (eg, orthostatic hypotension, syncope) in ambulatory patients.
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Increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (eg, phenothiazines or general anesthetics). Monitor these patients for signs of hypotension after initiating or titrating Nucynta.
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Avoid use of Nucynta in patients with circulatory shock because Nucynta may cause vasodilation in these patients that can further reduce cardiac output and blood pressure.
Risk of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness
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The use of Nucynta in patients with evidence of increased intracranial pressure or brain tumors may result in further increased intracranial pressure. Monitor these patients for signs of sedation and respiratory depression especially during initiation.
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Avoid use of Nucynta in patients with impaired consciousness or coma.
Risk of Use in Patients with Gastrointestinal Conditions
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Nucynta is contraindicated in patients with known or suspected GI obstruction, including paralytic ileus.
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Nucynta may cause spasms of the sphincter of Oddi and may cause increases in serum amylase. Monitor for worsening symptoms in patients with biliary tract disease, including acute pancreatitis.
Increased Risk of Seizures in Patients with Seizure Disorders
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Nucynta may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures.
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Monitor patients with a history of seizure disorders for worsened seizure control during therapy.
Withdrawal
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Avoid abrupt cessation in patients physically dependent on opioids. Gradually taper dosage when discontinuing Nucynta in a physically dependent patient.
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Rapid tapering of tapentadol in a physically dependent on opioids may lead to a withdrawal syndrome and return of pain.
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Avoid using with mixed agonist/antagonist (eg, pentazocine, nalbuphine, and butorphanol) or partial agonist (eg, buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including Nucynta.
Risks of Driving and Operating Machinery
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Nucynta may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
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Do not drive or operate dangerous machinery unless tolerant to Nucynta.
Interactions with Alcohol, Other Opioids, and Drugs of Abuse
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Do not consume alcoholic beverages or use prescription or nonprescription products (eg, alcohol, other opioids, or drugs of abuse while on therapy).
Risk of Toxicity in Patients with Hepatic Impairment
Risk of Toxicity in Patients with Renal Impairment